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    Summary
    EudraCT Number:2013-000476-14
    Sponsor's Protocol Code Number:TCI_BRIVA
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-19
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2013-000476-14
    A.3Full title of the trial
    TARGET-CONTROLLED INFUSION (TCI) WITH PROPOFOL AND REMIFENTANIL AS ANALGO-SEDATION IN WOUND CARE IN PATIENTS WITH BURNS
    MÅL-KONTROLLERAD INFUSION (TCI) MED PROPOFOL OCH REMIFENTANIL SOM ANALGO-SEDERING UNDER SÅRVÅRD HOS PATIENTER MED BRÄNNSKADA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TARGET-CONTROLLED INFUSION (TCI) WITH PROPOFOL AND REMIFENTANIL AS ANALGO-SEDATION IN WOUND CARE IN PEOPLE WITH BURNS
    MÅL-KONTROLLERAD INFUSION (TCI) MED PROPOFOL OCH REMIFENTANIL SOM ANALGO-SEDERING UNDER SÅRVÅRD HOS PERSONER MED BRÄNNSKADA
    A.3.2Name or abbreviated title of the trial where available
    TCI BRIVA
    TCI BRIVA
    A.4.1Sponsor's protocol code numberTCI_BRIVA
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLANDSTINGET I ÖSTERGÖTLAND
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLIO SINNESCENTRUM
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportSTEN-OTTO LILJEDAHLS FOND
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLANDSTINGET I ÖSTERGÖTLAND
    B.5.2Functional name of contact pointUNIVERSITETSSJUKHUSET I LINKÖPING
    B.5.3 Address:
    B.5.3.1Street AddressUNIVERSITETSSJUKHUSET I LINKÖPING
    B.5.3.2Town/ cityLINKÖPING
    B.5.3.3Post code58185
    B.5.3.4CountrySweden
    B.5.4Telephone number+46010103 18 20
    B.5.6E-mailfolke.sjoberg@lio.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRemifentanil
    D.3.9.1CAS number 132875-61-7
    D.3.9.3Other descriptive nameREMIFENTANIL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04215MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFentanyl
    D.3.9.1CAS number 990-73-8
    D.3.9.3Other descriptive nameFENTANYL CITRATE
    D.3.9.4EV Substance CodeSUB02129MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Burn patients who need analgo-sedation during wound care.
    Patienter med brännskada som behöver analgo-sedering under sårvård.
    E.1.1.1Medical condition in easily understood language
    Burn patients who need pain relief and sedation during wound care
    Patienter med brännskada som behöver smärtlindring och sedering under sårvård.
    E.1.1.2Therapeutic area Health Care [N] - Health Care Facilities, Manpower, and Services [N02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10028175
    E.1.2Term Multiple burns
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate whether Target-Controlled infusion (TCI) with propofol and remifentanil can be used as analgo-sedation on burn patients and if the method can shorten the recovery time after wound care compared with daily routine of continous infusion of propofol with intermittent bolus of fentanyl.
    Att utvärdera om Mål-kontrollerad infusion (TCI) med propofol och remifentanil kan användas vid analgo-sedering av brännskadade patienter och om metoden kan bidra till att förkorta tiden för återhämtning efter sårvård jämfört med en rutinmässig användning av kontinuerlig infusion av propofol och intermittenta bolusdoser med fentanyl.
    E.2.2Secondary objectives of the trial
    To evaluate whether Target-Controlled infusion (TCI) of propofol and remifentanil compared with routine use of continuous infusion of propofol and intermittent bolus doses of fentanyl can shorten the time until mobilisation and nutrition. Measurement of the total energy intake during the day for wound care are implemented as well the number of adverse events and the necessary interventions as well as the total dose administered analgesia and anti-emetics. Finally, the research estimates the perceived pain and experience during wound care. The staff at ward will after the wound care evaluate the wound care conditions.
    Att utvärdera om Mål-kontrollerad infusion (TCI) med propofol och remifentanil jämfört med en rutinmässig användning av kontinuerlig infusion av propofol och intermittenta bolusdoser med fentanyl kan förkorta tiden till att forskningspersonen mobilserar och nutrierar sig. Mätning av forskningspersonens totala energiintaget under dygnet för sårvården genomförs likväl antal adverse events och nödvändiga interventioner samt den totala dosen given smärtlindring och antiemetika. Slutligen skattar forskningspersonen den upplevda smärtan respektive upplevelsen under sårvården och avdelningspersonalen skattar sårvårdsbetingelserna under sårvården.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult patients (≥ 18 years) with burns regardless degree or extent.
    The patient should be hospitalized in a swedish burn center.
    The subject is planned for at least two consecutive occasions with wound care with analgo-sedation.
    The patient has given their consent to participate in the study.
    Vuxna patienter (≥18 år) med brännskada oavsett grad eller omfattning.
    Patienten skall vara inneliggande på brännskadecenter.
    Planeras att genomgå minst två på varandra efterföljande sårvårdstillfällen med analgo-sedering.
    Patienten har givit sitt samtycke till att delta i studien.
    E.4Principal exclusion criteria
    Patients who are ventilator treated.
    Mental or physical inability, unwillingness or language difficulties that causes difficulty to understand the meaning of participation in the study, according to the responsible physician.
    Wound care where bath is planned.

    Contraindications to study drug:
    Known or suspected allergy or hypersensitivity to oxycodone, propofol, remifentanil, morphine, selective 5-HT3 receptor antagonists, fentanyl analog, opioids, pregabalin, paracetamol, naproxen, peanuts or soy.
    Respiratory depression with or without hypoxia, hypercapnia, severe bronchial asthma patients who have had symptoms of asthma, rhinitis or urticaria after taking aspirin or other anti-inflammatory agents of non-steroidal nature, severe chronic obstructive pulmonary disease and cor pulmonale.
    Severe heart failure, hypovolemia and hypotension.
    Increased intracranial pressure or head injury.
    Myasthenia gravis.
    Conditions associated with increased bleeding, an ongoing or history of gastrointestinal bleeding or perforation.
    Cirrhosis of the liver.
    Kidney disease (glomerular filtration rate <30 ml / min).
    Paralytic ileus.
    Third trimester of pregnancy and during lactation.
    Concomitant use with MAO inhibitors or recent (within two weeks) discontinuation of MAO inhibitors.
    Patienter som vårdas i respirator.
    Mental eller fysisk oförmåga, ovilja eller språksvårigheter som medför svårighet att förstå innebörden av att delta i studien enligt inkluderande anestesiläkarens bedömning.
    Sårvård där sårvårds-bad planeras.

    Kontraindikationer för studieläkemedel:
    Känd eller misstänkt allergi eller överkänslighet mot oxykodon, propofol, remifentanil, morfin, selektiva 5-HT3-receptorantagonister, fentanylanaloger, opioider pregabalin, paracetamol, naproxen, jordnötter eller soja.
    Andningsdepression med eller utan hypoxi, hyperkapni, allvarlig bronkialastma, astmatiker som har fått symtom på astma, rinit eller urtikaria vid intag av acetylsalicylsyra eller andra antiinflammatoriska medel av icke-steroid natur, allvarlig kronisk obstruktiv lungsjukdom samt cor pulmonale.
    Svår hjärtsvikt, hypovolemi och hypotension.
    Förhöjt intrakraniellt tryck eller skallskador.
    Myastenia gravis.
    Tillstånd med ökad blödningsbenägenhet, aktiv eller anamnes på gastrointestinal blödning eller perforation.
    Levercirros.
    Njursjukdom (glomerulusfiltration <30 ml/min).
    Paralytisk ileus.
    Tredje trimestern av graviditeten och under amning.
    Samtidig medicinering med MAO-hämmare eller nyligen (inom två veckor) avslutad behandling med MAO-hämmare.
    E.5 End points
    E.5.1Primary end point(s)
    Time to recovery after analgo-sedation.
    Tid till återhämtning efter avslutad analgo-sedering.
    E.5.1.1Timepoint(s) of evaluation of this end point
    0-120 minutes
    0-120 minuter
    E.5.2Secondary end point(s)
    Time to mobilization after analgo-sedation.
    Time to nutrition post analgo-sedation.
    Energy intake during the day of wound care.

    During analgo-sedation:
    Adverse events (AE)
    interventions

    Postprocedure:
    Adverse events (AE)
    interventions
    Subjects estimation of subjective pain by using the VAS-scale
    Total dose of analgesics
    Total dose antiemetics

    Subjects subjective experience of the wound care by using the VAS-scale.
    Staffs experience of wound care conditions.
    Tid till mobilisering efter avslutad analgo-sedering.
    Tid till nutriering efter avslutad analgo-sedering.
    Energiintag under sårvårdsdygnet.

    Under analgo-sedering:
    Adverse events (AE)
    Interventioner

    Postproceduralt:
    Adverse events (AE)
    Interventioner
    Forskningspersonens skattning av smärta utifrån VAS
    Total dos analgetika
    Total dos antiemetika

    Forskningspersonens upplevelse under sårvårdstillfället utifrån VAS.
    Avdelningspersonalens upplevelse av sårvårdsbetingelserna under sårvården.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day of analgo-sedation (24h)
    Dag för analgo-sedering (24h)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-03-19. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    According to clinical pratice.
    Enligt klinisk rutin.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-10
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